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Cooperative Clinical Trials

  • Casey J. Allen
  • Giampaolo Perri
  • Matthew H. G. KatzEmail author
Chapter
  • 37 Downloads
Part of the Success in Academic Surgery book series (SIAS)

Abstract

Cooperative clinical trials play a major role in advancing knowledge in the fields of medicine and surgery. The National Cancer Institute provides a robust infrastructure to help carry out these important studies for cancer, although multicenter trials certainly can be conducted outside of this mechanism with enough planning and coordination. In addition to the inherent value of the education and contribution to the scientific field, involvement in cooperative group research affords the opportunities for networking and mentorship, leadership training and career development, scientific discovery and funding, all of which can add to personal career satisfaction.

References

  1. 1.
    Juni P, Altman D, Egger M. Assessing the quality of randomised controlled trials. In: Egger M, Smith GD, Altman DG, editors. Systematic reviews in health care: meta-analysis in context. 2nd ed. London: BMJ Publishing Group; 2001.Google Scholar
  2. 2.
    Levin WC, et al. Cooperative clinical investigation. A modality of medical science. JAMA. 1974;227(11):1295–6.CrossRefGoogle Scholar
  3. 3.
    Klimt CR. Principles of multi-center clinical studies. In: Boissel JP, Klimt CR, editors. Multi-center controlled trials. principles and problems. Paris: INSERM; 1979.Google Scholar
  4. 4.
  5. 5.
    Coronary Drug Project Research Group. The Coronary Drug Project: methods and lessons of a multicenter clinical trial. Control Clin Trials. 1983;4(4):1–541.Google Scholar
  6. 6.
    Meinert CL. Clinical trials. Design, conduct and analysis. New York, NY: Oxford University Press; 1986.CrossRefGoogle Scholar
  7. 7.
    Corless CL, et al. Pathologic and molecular features correlate with long-term outcome after adjuvant therapy of resected primary GI stromal tumor: the ACOSOG Z9001 trial. J Clin Oncol. 2014;32(15):1563–70.CrossRefGoogle Scholar
  8. 8.
    Giuliano AE, et al. Effect of axillary dissection vs no axillary dissection on 10-year overall survival among women with invasive breast cancer and sentinel node metastasis: the ACOSOG Z0011 (Alliance) randomized clinical trial. JAMA. 2017;318(10):918–26.CrossRefGoogle Scholar
  9. 9.
    Jang HJ, et al. The addition of bevacizumab in the first-line treatment for metastatic colorectal cancer: an updated meta-analysis of randomized trials. Oncotarget. 2017;8(42):73009–16.CrossRefGoogle Scholar
  10. 10.
    Sandler A, et al. Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer. N Engl J Med. 2006;355(24):2542–50.CrossRefGoogle Scholar
  11. 11.
    Early Breast Cancer Trialists' Collaborative Group, et al. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet. 2012;379(9814):432–44.CrossRefGoogle Scholar
  12. 12.
  13. 13.
    Institute of Medicine. A national cancer clinical trials system for the 21st century: reinvigorating the NCI Cooperative Group Program. Washington, DC: The National Academies Press; 2010.  https://doi.org/10.17226/12879.CrossRefGoogle Scholar
  14. 14.
  15. 15.
    Patlak M, et al. Multi-center phase III clinical trials and NCI cooperative groups: workshop summary, vol. xii. Washington, DC: National Academies Press; 2009. p. 121.CrossRefGoogle Scholar
  16. 16.
  17. 17.
  18. 18.
  19. 19.
  20. 20.
  21. 21.
  22. 22.
  23. 23.
  24. 24.
  25. 25.
  26. 26.
  27. 27.
  28. 28.
  29. 29.
    American College of Surgeons Clinical Research Program, Alliance for Clinical Trials in Oncology, Nelson HD, Hunt KK. Operative standards for cancer surgery, volume i: breast, lung, pancreas, colon. Philadelphia, PA: Wolters Kluwer Health; 2015.Google Scholar
  30. 30.
    American College of Surgeons Clinical Research Program, Alliance for Clinical Trials in Oncology, Katz MHG. Operative standards for cancer surgery, volume ii: thyroid, gastric, rectum, esophagus, melanoma. Philadelphia, PA: Wolters Kluwer Health; 2018.Google Scholar
  31. 31.
  32. 32.
    Friedman L, DeMets D. The data monitoring committee: how it operates and why. IRB. 1981;3:6–8.CrossRefGoogle Scholar
  33. 33.
    Fleming TR, DeMets DL. Monitoring of clinical trials: issues and recommendations. Control Clin Trials. 1993;14(3):183–97.CrossRefGoogle Scholar
  34. 34.
    Angell M, Kassirer JP. Setting the research straight in the breast-cancer trials. N Engl J Med. 1994;330:1448–50.CrossRefGoogle Scholar
  35. 35.
    Cohen J. Clinical trial monitoring: hit or miss? Science. 1994;264(5165):1534–7.CrossRefGoogle Scholar
  36. 36.
    Uy GL, Katz MHG, Boughey JC. Junior investigators: get engaged in the Alliance for Clinical Trials in Oncology. Bull Am Coll Surg. 2017;102(4):62–3.PubMedPubMedCentralGoogle Scholar
  37. 37.
    Eisenstein EL, et al. Sensible approaches for reducing clinical trial costs. Clin Trials. 2008;5(1):75–84.CrossRefGoogle Scholar
  38. 38.
    Chung KC, Song JW, W.S. Group. A guide to organizing a multicenter clinical trial. Plast Reconstr Surg. 2010;126(2):515–23.CrossRefGoogle Scholar
  39. 39.
    Krueger RA, Casey MA. Focus groups: a practical guide for applied research. Thousand Oaks, CA: Sage Publications; 2006.Google Scholar
  40. 40.
    Van de Ven AH, Delbecq AL. The nominal group as a research instrument for exploratory health studies. Am J Public Health. 1972;62:337–42.CrossRefGoogle Scholar
  41. 41.
    Dalkey NC. The Delphi method: an experimental study of group opinion. Santa Monica, CA: RAND Corp; 1969.Google Scholar
  42. 42.
    Katz MH, et al. Standardization of surgical and pathologic variables is needed in multicenter trials of adjuvant therapy for pancreatic cancer: results from the ACOSOG Z5031 trial. Ann Surg Oncol. 2011;18(2):337–44.CrossRefGoogle Scholar
  43. 43.
    Phillips RK, et al. Local recurrence following ‘curative’ surgery for large bowel cancer: I. The overall picture. Br J Surg. 1984;71(1):12–6.CrossRefGoogle Scholar
  44. 44.
    Stocchi L, et al. Impact of surgical and pathologic variables in rectal cancer: a United States community and cooperative group report. J Clin Oncol. 2001;19(18):3895–902.CrossRefGoogle Scholar
  45. 45.
    Holm T, et al. Influence of hospital- and surgeon-related factors on outcome after treatment of rectal cancer with or without preoperative radiotherapy. Br J Surg. 1997;84(5):657–63.CrossRefGoogle Scholar
  46. 46.
    Kockerling F, et al. Influence of surgery on metachronous distant metastases and survival in rectal cancer. J Clin Oncol. 1998;16(1):324–9.CrossRefGoogle Scholar
  47. 47.
    Nelson H, et al. Guidelines 2000 for colon and rectal cancer surgery. J Natl Cancer Inst. 2001;93(8):583–96.CrossRefGoogle Scholar
  48. 48.
    American Joint Committee on Cancer. Exocrine pancreas. In: Greene FL, Page DL, Fleming ID, et al., editors. AJCC cancer staging manual. 6th ed. Chicago, IL: Springer; 2002. p. 157–64.CrossRefGoogle Scholar
  49. 49.
    College of American Pathologists. Cancer protocols [16 August 2010]; Pancreas (exocrine); 2009. http://www.cap.org/apps/docs/committees/cancer/cancer_protocols/2009/PancreasExo_09protocol.pdf.
  50. 50.
    American Joint Committee on Cancer. Exocrine pancreas. In: Edge SB, Byrd DR, Compton CC, et al., editors. AJCC cancer staging manual. 7th ed. Chicago, IL: Springer; 2009. p. 241–9.Google Scholar
  51. 51.
    Menon KV, et al. Impact of margin status on survival following pancreatoduodenectomy for cancer: the Leeds Pathology Protocol (LEEPP). HPB (Oxford). 2009;11(1):18–24.CrossRefGoogle Scholar
  52. 52.
    Staley CA, et al. The need for standardized pathologic staging of pancreaticoduodenectomy specimens. Pancreas. 1996;12(4):373–80.CrossRefGoogle Scholar
  53. 53.
    Chatelain D, Flejou JF. Pancreatectomy for adenocarcinoma: prognostic factors, recommendations for pathological reports. Ann Pathol. 2002;22(5):422–31.PubMedGoogle Scholar
  54. 54.
    Luttges J, Zamboni G, Kloppel G. Recommendation for the examination of pancreaticoduodenectomy specimens removed from patients with carcinoma of the exocrine pancreas. A proposal for a standardized pathological staging of pancreaticoduodenectomy specimens including a checklist. Dig Surg. 1999;16(4):291–6.CrossRefGoogle Scholar
  55. 55.
    Khalifa MA, Maksymov V, Rowsell C. Retroperitoneal margin of the pancreaticoduodenectomy specimen: anatomic mapping for the surgical pathologist. Virchows Arch. 2009;454(2):125–31.CrossRefGoogle Scholar
  56. 56.
    Verbeke CS, et al. Redefining the R1 resection in pancreatic cancer. Br J Surg. 2006;93(10):1232–7.CrossRefGoogle Scholar
  57. 57.
    Nagtegaal ID, et al. Macroscopic evaluation of rectal cancer resection specimen: clinical significance of the pathologist in quality control. J Clin Oncol. 2002;20(7):1729–34.CrossRefGoogle Scholar
  58. 58.
    Stevenson AR, et al. Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: the ALaCaRT randomized clinical trial. JAMA. 2015;314(13):1356–63.CrossRefGoogle Scholar
  59. 59.

Copyright information

© Springer Nature Switzerland AG 2020

Authors and Affiliations

  • Casey J. Allen
    • 1
  • Giampaolo Perri
    • 1
  • Matthew H. G. Katz
    • 1
    Email author
  1. 1.Department of Surgical OncologyUniversity of Texas MD Anderson Cancer CenterHoustonUSA

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